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Contraindications for ROTARIX include a history of any of the following: hypersensitivity to the vaccine or any component of the vaccine, intussusception, uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception, or Severe Combined Immunodeficiency Disease (SCID)

Study design:
A randomized, double-blind, placebo-controlled study was conducted in 6 European countries comparing ROTARIX (n=2572) vs placebo (n=1302). The first dose was given at 6-14 weeks of age, and the second dose was given at least 4 weeks after the first dose. The 2-dose series was completed by 24 weeks of age. Analysis of the ATP cohort included all infants in the efficacy cohort who received 2 doses of vaccine according to randomization. "toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"[1,2]

Indication

ROTARIX is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series. ROTARIX is approved for use in infants 6 weeks to 24 weeks of age.

Important Safety Information

Contraindications for ROTARIX include a history of any of the following: hypersensitivity to the vaccine or any component of the vaccine, intussusception, uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception, or Severe Combined Immunodeficiency Disease (SCID)

The tip caps of the prefilled oral applicators of diluent contain natural rubber latex, which may cause allergic reactions

Administration in infants suffering from acute diarrhea or vomiting should be delayed. Safety and effectiveness in infants with chronic gastrointestinal disorders have not been evaluated

Safety and effectiveness in infants with known primary or secondary immunodeficiencies have not been established

A study conducted after approval of ROTARIX showed an increased risk of intussusception in the 31 days after the first dose of ROTARIX, especially in the first 7 days. In other reports, an increased risk of intussusception has been observed within 7 days after dose 2

In clinical studies, common adverse reactions in infants receiving ROTARIX included fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting

Vaccination with ROTARIX may not result in protection in all vaccine recipients

References

Important Safety Information

Contraindications for ROTARIX include a history of any of the following: hypersensitivity to the vaccine or any component of the vaccine, intussusception, uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception, or Severe Combined Immunodeficiency Disease (SCID)

The tip caps of the prefilled oral applicators of diluent contain natural rubber latex, which may cause allergic reactions

Administration in infants suffering from acute diarrhea or vomiting should be delayed. Safety and effectiveness in infants with chronic gastrointestinal disorders have not been evaluated

Safety and effectiveness in infants with known primary or secondary immunodeficiencies have not been established

A study conducted after approval of ROTARIX showed an increased risk of intussusception in the 31 days after the first dose of ROTARIX, especially in the first 7 days. In other reports, an increased risk of intussusception has been observed within 7 days after dose 2

In clinical studies, common adverse reactions in infants receiving ROTARIX included fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting

Vaccination with ROTARIX may not result in protection in all vaccine recipients

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report, or call 1-800-822-7967